The present invention relates to the treatment or therapeutic care of diabetes, to devices for use in diabetes care, and to methods of making and using such devices, and to methods of treatment or care of diabetes. In some embodiments, the present invention relates to at least one of a system, a diagnostic tool, a therapeutic tool and an educational tool for diabetes self-management. In some embodiments, the present invention relates to a medical device for use in diabetes care, e.g. a blood glucose meter, an insulin pump or a continuous glucose monitoring device. In some embodiments, the present invention relates to program, method or process for diabetes management, and to a data carrier including such a program.
Considerable progress has been made in the development of diagnostic, therapeutic and educational tools for diabetes self-management. However, it is less recognized that in the daily life of people with diabetes mellitus all such tools are characterized by rather large and varying margins of error. There exists insufficient knowledge about the effects of such errors on postprandial blood glucose and, thus, about their contribution to the increases risk of hypoglycemia and hyperglycemia.
Some currently known systems, and in particular systems for continuous glucose monitoring, do not display actual results to avoid a possibly false therapy decision based on an uncertain measuring value (a value with a measuring error that could be too large). With such systems only a retrospective analysis of the measured values is possible. [Mastrototaro J. The MiniMed Continuous Glucose Monitoring System. Journal of Pediatric Endocronology & Metabolism, 12, 751-758 (1999)].
Other systems for continuously monitoring glucose do display actual measurement values, but are not approved for therapy decisions. For such decisions it is in both cases necessary to measure the blood glucose value with strip measurement devices. [FDA Approval order GlucoWatch Automatic Glucose Biographer-P990026, http://www.fda.gov/cdrh/pdf/p990026.html].
According to the manufacturer's information a system for continuous glucose monitoring shall be able to allow therapy decision without confirmaton by a conventional measuring system. [Feldman B, Brazg R, Schwartz S, Weinstein R. A Continuous Glucose Sensor Based on Wired Enzyme Technology. Diabetes Technology & Therapeutics, 5, 5, 769-779, 2003].